Client: Haleon
Location: Nyon
Job Category: Quality Assurance
Job Reference: 3343d765d223
Job Views: 3
Posted: 14.03.2025
Expiry Date: 28.04.2025
Job Description:
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people.
This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.
About the role
* Lead internal audits of GSK Nyon plant departments to identify non-compliance with the GSK QMS, National / International GxP requirements, and Local Standard Operating Procedures.
* Local process owner for self-inspection, internal and external audits.
* Support Inspection/Audit of Nyon plant by Health Authorities, GSK group, Customers, and Notified Body, prepare audit and Inspection answers, follow action plan and document action closure.
* Manage Documentation and training activities.
Key Responsibilities
1. SELF INSPECTION: Local process owner of the Self-Inspection process: define SOP and template according to Global CH guidance, define training program, review and approve audit universe, define and report KPIs, trends findings and escalate any significant gaps.
2. INTERNAL AUDIT: Local process owner of the Internal Audit process: define SOP and template, define training program, conduct internal audit and issue report, approve proposed CAPA, follow CAPA closure on time.
3. EXTERNAL AUDIT: Local process owner of the External Audit process for Nyon site services providers. Define SOP and template, define training program, conduct external audit and issue report, approve proposed CAPA, follow CAPA closure on time.
4. Support the QA Release, Compliance and Auditing Senior Manager for audit/inspection organization.
5. Manage CAPA follow up in accordance with Global CH guidance and local SOP.
6. Verify implementation and effectiveness of agreed corrective/preventive actions.
7. Issue monthly report for KPIs and trend audit observations.
8. CONTINUOUS IMPROVEMENT: SME for Auditing process, author and review Standard Operating Procedures.
9. DOCUMENTATION: Oversee the design, delivery, development and renewal of the site’s documentation program.
10. TRAINING: Design, deliver, implement, and maintain a comprehensive training program for the Nyon manufacturing plant.
11. PEOPLE MANAGEMENT: Management of direct reports which includes independent contributors and managers of other associates.
12. GMP and HSE: Respect all GxP standards and HSE requirements at Nyon plant.
Qualifications and skills
* University degree in Quality Assurance, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
* Minimum 5 years of experience in the pharmaceutical industry within the quality assurance function.
* Experience in auditing activities.
* Haleon/GSK certified auditor.
* Good interpersonal and leadership skills.
* Safety, Quality, Results and Customer oriented.
* Previous people management experience.
* Fluency in French and English.
* Excellent knowledge of GMP and regulatory expectations.
* Ability to influence people.
* Role model in GxP, HSE and Haleon values expectation.
Diversity, Equity and Inclusion
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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